PHS 398 (Rev. 9/04), Continuation Page



This document is based on PHS 398 forms revised 06/09, and current as of March 2012. The program announcement for the K99 is

This document is just something we’ve prepared to help you with your application. You can read the NIH book (SF 424) for complete details. Pay special attention to Section 7.

Getting Started.

Rule #1—Don’t Panic.

Rule #2—Writing is an iterative process. Don’t expect it to be perfect the first time you put it on paper. Just start putting it down. Start with the outline below, and your proposal will slowly come alive (see Rule #1).

Rule #3—You are not in this alone. Everyone wants you to be successful. Let your mentor and co-workers help.

Rule #4—Elements of style, by Strunk and White. This is a book you should own. Amazon offers the Strunk version on Kindle for $2.99, and there’s even an illustrated form. I like the 1999 edition, myself. 105 pages of pure brilliance. Buy it. Read it.

Rule #5—Paragraph construction. The paragraph has a simple form. The first sentence tells you what the paragraph is about. The following sentences explain, in some rational order, what you want to tell them. The last sentence should summarize what you told them or transition to the next paragraph.

Rule #6—Key words. The strongest scientific paragraphs start with a key word. Breast Cancer is a key word. You will discover that your scientific writing is most powerful when you begin with key words. Let’s rewrite that sentence starting with the key word: Key words will add power to your scientific writing. I submit that the second sentence is more powerful. Think about it. The reviewer knows exactly what you are talking about as soon as he or she reads the first word. It’s tighter. Strunk and White state to omit unnecessary words. This is also important when your grant is only 12 pages long.

Rule #7—Tense. Keep a paragraph in the same tense. Try to keep whole sections in the same tense.

Rule #8—Tone and person. We are taught to write in a passive tone and third person. One is told that the passive tone makes one’s proposal sound more clinical and objective. I feel that passive tone and third person is boring, pretentious, and fake sciency. I want my grant to read like a good fiction novel—I want to build tension, tell a good story, give the reviewer a good reading experience. I also find that it’s easier to write about myself in the first person, and you’ll be writing about yourself for several sections. Other scientists feel that one should always write science in a dispassionate fashion. Whichever you decide, just try to be consistent.

Is the K99 right for you? If you are in the first 1-3 years of postdoc, with a few first author publications or a high impact publication, this could be right for you. If you are clinical, you might want to look at other K opportunities with higher funding rates. If you are four or more years out from your last degree, maybe an R03, R21 or R01 is a better mechanism for you. (As an aside, almost all the institutes funded R01s at a higher level than R21s. If you have enough preliminary data, I’d recommend going for the big one). Talk with your mentor, and find out which types of grants have the highest success rates. You can see the application and award numbers by institute for the last ten years here:

While looking at success rates, pay attention to the institution. For example, NIEHS had 17 K99 applications in 2007, and funded 6 (35%) while NEI had 24 K99 applications, and funded only 4 (17%). Your project might be appropriate for two different institutes (say, cancer caused by an environmental agent) so you might want to target your application to the one that had a better success rate in 2007. In 2011, NIEHS had 15 applications, funding 8 (53.3%). NIDDK had 46 and funded 7 (15%).

Getting started:

1. First steps: Find your grants administrator (GA), and get an eRA commons user name. Your GA will probably be the GA of your primary mentor, but this is up to your business office. The business office will assist you with applying for the eRA commons name—which you MUST have in order to submit. Our office has to submit the grant to SRS (sponsored research services) 5 business days before the deadline. The earlier you interact with the GA, the easier your life will be. Given enough forewarning, your GA will assist you in preparing the budget and any other administrative pages. I find that the earlier you get together with your GA, the smoother this process becomes. You prepare for these deadlines months in advance. Submitting at the last minute increases the probability of mistakes or shoddy work getting through.

2. The K99 requires at least 3 (but no more than 5) letters of reference. The letters should be from individuals not directly involved in the application, but who are familiar with the applicant’s qualifications, training, and interests. The reference letters are critically important and should address the candidate's (1) competence and (2) potential to develop into an independent biomedical or behavioral investigator. You should offer (and expect) to write the first draft of these letters yourself. Don’t be shy—get drafts of other letters of recommendation. Send this request to your old mentors as early as possible!!! The letter needs to be submitted electronically by the referee. Instructions for Referees: (these instructions are also found at: )

You need to give your eRA Commons name to the referees, so take care of the step in the paragraph above, first. You will receive email notification when your referees submit their letters.

3. Check with your NIH institute to see if it has different guidelines: Scroll down to the institute you think is best for your project, and note any specific information. I am also a big fan of emailing your program administrator, to ask them to look over your specific aims or a brief (three sentence) description of your project, to let you know if your work is appropriate for that institute. These folks get paid your tax dollars to fund the best projects for their institutes. Help them do their job!

4. Speaking of YOUR institute, go to the home page and read about the mission of that particular institute. I’m most familiar with NIEHS, but all of them tell you interesting facts about what they want to fund. A complete list can be found here: .

Parts of the grant application:

1. Cover Letter

Must include name, department, and institute of people who are writing letters of recommendation.

2. Project Summary and Relevance

The first major component of the Description is a Project Summary.

Provide an abstract of the whole application (candidate, environment, and research). Include the candidate's immediate and long-term career goals, research career development plan, and a description of the research project. This is the first impression of your work—make it excellent! Bold introductory sentence, clear hypothesis, specific aims that support the hypothesis, and how this project will TRAIN YOU! I tend to write an outline of this section first thing, then I go back after the whole grant is written and rewrite this. When your grant hits the study section, this is the first thing most people will read before your grant gets discussed.

3. The second component of the Description is Relevance. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience. My mom should be able to read this.

Key personnel: That’s you. Mentors go in as significant contributors.

4. Budget

Most of the time: Can’t exceed $90,000. Limited to $20,000 for all research support (travel, supplies). Indirects at 8%. However, this can differ by institute. Did you check?

Your grants person can fill this out, if you give them lead time. You will have to write a justification.

5. Biosketch—new format



The Biosketch requires a personal statement. I recommend the link below for some information. Your mentor’s biosketch will also need a personal statement. Get permission to rewrite this section.

We recommend writing a three-paragraph personal statement of at least one-half page, with subheadings as follows.

• Proposal Goal. This would be a brief, one-two sentence overview of what the proposal is trying to accomplish in big picture terms. Remind the reviewers what your proposal target is before you persuade them that you can reach that target.

• Relevant Experiences. As you write this paragraph, lift up the different types of experiences you have had, e.g., academic experience, administrative experience, research experience, mentoring experience, research experience.

• Leadership Qualification. In this section, you describe why your relevant experiences qualify you for your role in the project. For example, if you were to be the Principal Investigator (PI) in a project, you might indicate that your prior experiences form a solid foundation to assume the PI role because you have developed administrative skills essential to manage large scale projects that also require a broad range of people skills. You want to point out that you have the ability to manage, decide, and set priorities. Your past experiences have shown that you accept responsibility and carry out action plans. Your communication skills motivate others to accept responsibility and achieve. Use your relevant experiences to show how those developed skills transfer to essential leadership qualifications.

Outline of your grant. I like to copy and paste this outline into a new document, referring back to the instructions as I create the document. This gives me an outline, and makes sure that I don’t skip an important metric. Each section below contains my own thoughts on the topic, information from the SF 424 guide, and information from the Program Announcement (PA) for the K99, including review criteria. Use this outline for the beginning of your grant. You will see exactly what information is requested, and I think you will find that makes the non-science portion of your proposal easier to put down on paper.

1. Introduction to resubmission—You don’t need this if it’s your first submission.

Sections 2-5 Candidate Information (Note: Items 2-4 AND 11 combined are limited to 12 pages.

Most people use just 2-3 pages for Items 2-4, but I think it’s important to remember that a training grant is paying to produce two products: Research AND a trained investigator who will go on to do more great research. The original K99 had a 50:50 split.

2. Candidate's Background—Market yourself on paper! Remember—the NIH is funding YOU, not just your science. You need to explain why you rock, and how this training plan will prepare you to do incredible research that will have an impact on human health. Think about your background; what is special about you. List metrics, such as publications, awards, not worrying at first if it is related to you as a scientist. It is very hard for most people to market themselves on paper, so don’t feel bad.

Use this section to provide any additional information not described in the Biographical Sketch Format Page such as research and/or clinical training experience.

This is from the Program Announcement:

• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of one of the participating NIH ICs.

• Describe the candidate’s potential to develop into a successful independent investigator.

• Describe the candidate’s current as well as long-term research and career objectives.

• If currently supported by an institutional or individual Ruth L. Kirschstein NRSA, describe the candidate’s current research training or fellowship program.

• For individuals in postdoctoral positions with other titles although still in non-independent training positions, describe evidence of non-independence.

Review Criteria (make sure your description answers these questions):

• What is the candidate’s record of research productivity, including the quality of peer-reviewed scientific publications? (Translation: If you don’t have a couple publications, this application is going to be weak).

• What is the quality of the candidate's pre- and postdoctoral research training experience, including expertise gained? (Translation: Did you show metrics of success, including mastery of new techniques?).

• Based on the postdoctoral candidate’s experience, track record and prior research training, what is the candidate’s potential to become an outstanding, successful independent investigator who will contribute significantly to his/her chosen field of biomedical-related research? (Did you write this section to show that you have been working towards becoming an independent expert in your field?)

• To what extent does the application provide evidence of the candidate’s research creativity, and does this evidence suggest that the candidate has the potential to develop a creative, independent research program? (Did your writing describe at least one situation where you took the lead and solved a problem?)

• Given the candidate’s prior training, proposed career development plan, and the referees’ evaluations, is it reasonable to expect that the candidate will be able to achieve an independent, tenure-track or equivalent position within the time period requested for the K99 phase of this award?

• Do the letters of reference from at least three well-established scientists address the above review criteria, and do they demonstrate evidence that the candidate has a high potential for becoming an independent investigator?

• Relative to the above review criteria, how do these scientists evaluate the candidate?

• Do the letters provide strong evidence that the candidate has a high potential to become an independent investigator?

3. Career Goals and Objectives: Scientific Biography

Describe your past scientific history, indicating how the award will fit into past and future research career development. If there are consistent themes or issues that have guided previous work, these should be made clear; if your work has changed direction, the reasons for the change should be indicated. It is important to justify the award and how it will enable you to develop or expand your research career. I like to note gaps in training (for example, you realized that you couldn’t do this without flow cytometry, you needed statistics, and how you addressed these gaps—and what are the current gaps that this training plan will fill). You may include a timeline, including plans to apply for subsequent grant support. If you are a non-traditional (i.e. did not do 4 year BS, then 5 year PhD followed immediately by postdoc position) you need to address any time that was spent in a non-traditional manner.

From the Program Announcement:

• Present a systematic plan that: (1) shows a logical progression from the candidate’s prior research and training experiences to the training and research experiences proposed for the mentored phase of the award (K99) and subsequently to independent investigator status (R00); (2) justifies the need for further mentored career development to become an independent research investigator; and (3) that utilizes the relevant research and educational resources of the institution.

• Candidates planning to be sponsored by an extramural institution should consult with the proposed mentor to discuss the proposed research training/career development plan for the mentored phase and the research plan to be presented in the application for the subsequent independent scientist phase.

Review Criteria:

• Are the content and duration of the proposed didactic and research components of the career development plan appropriate for the candidate’s current stage of scientific and professional development and proposed research career goals?

• Is the proposed career development plan likely to contribute substantially to the scientific and professional development of the candidate including his/her successful transition to independence? (How will this work differentiate you from your mentor? This is why a mentor TEAM is good—you can propose to fill an expertise gap by combining training from two fields).

• For individuals currently supported by research training programs, how does the proposed career development plan enhance or augment the applicant’s training to date? (Your K99 should be an extension of the programmatic theme of your T32).

• Is the additional proposed training needed and appropriate for the proposed research plan and the applicant’s future career plans?

• To what extent are the plans for evaluating the K99 awardee’s progress adequate and appropriate for guiding the applicant towards a successful transition to the independent phase of the award?

• Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for the K99 phase of the award?

4. Career Development/Training Activities During Award Period

Stress the new enhanced research skills and knowledge you will acquire as a result of the proposed award (and tell them why the scientific community needs more people trained in this area with these skills). If you have considerable research experience in the same areas as the proposed research, reviewers may determine that the application lacks potential to enhance your research career. For mentored awards, describe structured activities, such as course work or technique workshops, which are part of the developmental plan. If course work is included, provide course numbers and descriptive titles. Briefly discuss each of the activities, except research, in which you expect to participate. Include a percentage of time involvement for each activity by year, and explain how the activity is related to the proposed research and the career development plan.

These are your metrics, or measurable, or benchmarks. For example, you want to learn how to analyze microarray data, so will work with a research scientist under the mentorship of Mario Medvedovic for four months in year one. You anticipate that this work will result in a publication on which you will be a minor (middle) author. You can refer to the science here: In Specific Aim 2, I will perform flow cytometry experiments under the tutelage of Alvaro Puga and his research assistant, adding this valuable skill to my research toolbox. These metrics need to also show up in Section 6 Mentoring Plan and Section 7 Statements by sponsors. You should write up drafts of both Section 4 and Section 6 with your mentor—they should be in complete agreement as to what you are expected to learn, how you will learn it, and how this learning will be measured.

I am a big fan of tables and bullet lists. It is easier for the reviewer to read what you want to do in bullets than in a narrative form. A table of activities, description, time required, and product can be easily scanned by reviewers.

From the Program Announcement:

• Describe the career development plan and how it fits with the candidate’s goals and prior experience. A systematic plan should be presented for obtaining the necessary biomedical, behavioral, or clinical science background and research experience to launch an independent research career. The career development plan must be specifically tailored to meet the needs of the candidate and the ultimate goal of achieving independence as a researcher.

• Describe the current training activities and how they relate to the career development plans and the career goals of the candidate. Candidates must justify the need for the award, both the mentored phase and the independent scientist phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored candidate followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem. (Why does science need you to be trained in this area? What is the benefit to the medical community and the United States if you accomplish this training?)

• The candidate should describe how the career development plan will promote the candidate’s success and scientific independence. This plan should describe activities such as those that will lead to new and/or enhanced research, grant-writing, communication and laboratory management skills and knowledge. The candidate should also describe how these skills will contribute to research productivity and facilitate the development of new approaches and directions for investigation. Courses or other activities that might allow the candidate to expand the scope of his/her research in order to improve the potential for success in gaining further independent funding are particularly encouraged.

• The candidate must describe the plan for evaluation of his/her progress during the mentored phase and for the transition to the independent phase. (You need to list metrics of success—how you will evaluate).

• The candidate and K99 phase mentor (see below) must describe plans for the transition to the independent phase. (And these plans should be similar!)

5. Training in the Responsible Conduct of Research Page limit=1

All CDA applications must describe a plan to acquire (or provide) training in the responsible conduct of research. The CEG or CCTST can supply you with some templates for this section. Personalize them! For mentored career development awards, describe a plan to acquire instruction in the responsible conduct of research. Attach a description of plans for obtaining instruction in the responsible conduct of research. This section should document prior instruction or participation in RCR training during the applicant’s current career stage (including the date instruction was last completed) and propose plans to either receive instruction or participate as a course lecturer, etc., in order to meet the once every four-year requirement. The plan should address how applicants plan to incorporate the five instructional components outlined in the NIH Policy on Instruction in the Responsible Conduct of Research: format, subject matter, faculty participation, duration, and frequency. The plan may include career stage-appropriate individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the mentor in RCR instruction must be described.

From the PA:

• Applications must include a plan to obtain instruction in the responsible conduct of research.

• This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research.

• Such plans must address five instructional components, format, subject matter, faculty participation, duration of instruction, and frequency of instruction, as outlined and explained in NOT-OD-10-019.

• The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant’s understanding of ethical issues related to their specific research activities and the societal impact of that research.

• The role of the sponsor/mentor in responsible conduct of research instruction must be described. Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or may not be reviewed .

• The background, r ationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

Sections 6-9 Mentors, Environment and Institutional Support

6. Mentoring Plan 6 pages.

The plan should provide information about the candidate’s commitment to serve as a mentor to other investigators, and describe previous mentoring activities. The plan should describe the setting and provide information about the available pool of mentees with appropriate backgrounds and interests in the same field of science. It should also include information on the candidate’s past and proposed mentees sufficient to evaluate the quality of prior mentoring experiences, including the professional levels of mentees, and the frequency and kinds of mentoring interactions between the candidate and the mentees. Describe the productivity of the mentoring relationship for the scientific development of the new scientists as judged by their publications and current research activities. Senior level (K05) candidates should describe any financial and material support from their own funded research and research resources that will be available to their mentees. The candidate’s proposed percent effort commitment to the mentoring plan should also be stated.

This section needs to repeat and expand on what you wrote in section 4 above. Yes, you are going to write this section, too, with input from your mentor. Refer to both training in section 4 above, section 7 below, and science in section 11. Sometimes reviewers look for mistakes—conflicting information—in order to score your grant poorly. A sloppy grant with conflicting plans indicates that this person is not on the ball, so we don’t have to feel badly about giving you a bad score.

From the PA:

• The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the K99 phase program. The candidate may also identify co-mentors as appropriate to the goals of the program. (It seems that multi-mentor proposals are currently scoring better. It’s also easier to show how you will differentiate yourself from your mentor if you have other mentors from whom you can draw expertise.)

• The primary mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.

• The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of this award.

• The application must include a statement from the mentor(s) that provides: 1) information on their (the mentor’s) research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the candidate’s scientific and professional independence will be promoted; 3) a description of the elements of the planned research training, including any formal course-work; and 4) a plan for transitioning the candidate from the mentored phase to the independent scientist phase of the award.

• Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should describe clearly how they will coordinate with the primary mentor and the candidate. (You need a chain of command—who has the final say in your training. Do you have a plan to deal with disagreements?)

• The mentor must agree to provide annual evaluations of the candidate’s progress for the initial mentored phase as required in the annual progress report. (What will be the metrics on which you will be evaluated? Publications? Seminars attended? Seminars given? Meetings or workshops?)

• The mentor must agree to review and comment on the extramural independent scientist (R00) phase application.

• Consultant(s)/Collaborator(s): Signed statements must be provided by each consultant/collaborator confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator. (These are not the same as mentors or co-mentors. A collaborator might be someone who lets you use equipment in her lab, or someone who is willing to share data with you).

Review Criteria:

• To what extent does the mentor have a strong track record in training future independent researchers?

• To what extent are the mentor’s research qualifications and experience, scientific stature, and mentoring track record appropriate for the applicant’s career development needs?

• Do(es) the mentor(s) adequately address the above review criteria including the candidate’s potential as well as his/her strengths and areas needing improvement?

• Is the proposed supervision that will occur during the mentored phase of support adequate, and is the commitment of the mentor(s) to the applicant’s continued career development appropriate?

• Does the mentor have a comprehensive plan to support the proposed K99 phase career development and research plans as well as the candidate’s efforts to transition to independence? Is this plan adequate and appropriate?

• Are the consultants’/collaborators’ research and/or mentoring qualifications appropriate for their roles in the proposed K99 phase of the award?

7. Statements by Sponsor, Co-Sponsor(s), Consultant(s), and Contributor(s)—Limit 6 pages

This section is to be completed by the sponsor, co-sponsor(s), consultant(s), and contributor(s), as appropriate. Each of your mentors can write here. In reality, you write this, making sure it corresponds with training plan above (and you can use this section to explain training in detail, if needed). This is not the time to be humble. Put words in your sponsor’s mouths. They will change anything they don’t like.

1. The plan for the candidate's training and research career development. This description must include not only research, but also other developmental activities, such as seminars, scientific meetings, training in the responsible conduct of research, and presentations. It should discuss expectations for publications over the entire period of the proposed project and define what aspects of the proposed research project the candidate will be allowed to take with him/her to start their own research program.

2. The source of anticipated support for the candidate’s research project for each year of the award period.

3. The nature and extent of supervision and mentoring of the candidate, and commitment to the candidate's development that will occur during the award period.

4. The candidate's anticipated teaching load for the period of the award (number and types of courses or seminars), clinical responsibilities, committee and administrative assignments, and the portion of time available for research.

5. A plan for transitioning the candidate from the mentored stage of his/her career to the independent investigator stage by the end of the project period of the award. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes.

All mentored career development applications should identify all co-mentors, consultants and collaborators involved with the proposed research and career development program. Briefly describe their roles and anticipated contributions. A co-mentor must specifically address the nature of his/her role in the career development plan and how the responsibility for the candidate’s development is shared with the mentor. Describe respective areas of expertise and how they will be combined to enhance the candidate’s development. Also describe the nature of any resources that will be committed to this CDA. Letters from the mentor(s), co-mentor(s), consultant(s), advisory committee members (if applicable), and contributor(s) documenting their role and willingness to participate in the project must be included in this section of the application. Do not place these letters in the Appendix.

8. Description of Institutional Environment—Limit one (1) page.

The sponsoring institution must document a strong, well-established research program related to the candidate's area of interest, including the names of key faculty members relevant to the candidate's proposed developmental plan. Referring to the resources description (See section 4.4.10 Facilities and Other Resources), indicate how the necessary facilities and other resources will be made available for career enhancement as well as the research proposed in this application. Describe opportunities for intellectual interactions with other investigators, including courses offered, journal clubs, seminars, and presentations.

We have lots of paragraphs describing the resources available to you, but this should be highly customized for your research and career development. The more you refer back to your training plan and science, the more thoughtful and less “canned” your grant will appear.

From the PA:

• The sponsoring institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.

• Describe the sponsoring institution’s scientific environment including the resources and facilities that will be available to the candidate.

• Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan and progression to the R00 phase.

9. Institutional Commitment to the Candidate's Research Career Development—One (1) page

This letter needs to come from your department head. You should expect to write the draft for them, weeks ahead of time.

The institution should provide a document on institutional letterhead that describes its commitment to the candidate and the candidate’s career development, independent of the receipt of the CDA (this grant). The document should include the institution’s agreement to provide adequate time and support for the candidate to devote the proposed protected time to research and career development for the entire period of the proposed award. The institution should provide the equipment, facilities, and resources necessary for a structured research career development experience. It is essential to document the institution's commitment to the retention, development and advancement of the candidate during the period of the award.

Agreement

The applicant organization must:

a. Agree to release the candidate from other duties and activities to devote the required percentage of time for development of a research career. For most K awards, commitment of at least 75 percent of time is required. Describe actions that will be taken to ensure this; e.g., reduction of the candidate's teaching load, committee and administrative assignments, and clinical or other professional activities for the current academic year. (For example, describe the actions that will be taken to compensate for the reduction in clinic responsibilities of the candidate, e.g., hiring of additional staff). Describe the candidate's academic appointment, bearing in mind that it must be full-time, and that the appointment (including all rights and privileges pertaining to full faculty status if in an academic setting) and the continuation of salary should not be contingent upon the receipt of this award. Describe the proportion of time currently available for the candidate's research experience and what the candidate's institutional responsibilities will be if an award is made.

b. Provide the candidate with appropriate office and laboratory space, equipment, and other resources and facilities (including access to clinical and/or other research populations) to carry out the proposed Research Plan.

c. Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

Signatures

The institutional commitment must be dated and signed by the person who is authorized to commit the institution to the agreements and assurances listed above. In most cases, this will be the dean or the chairman of the department. The signature must appear over the signer's name and title at the end of the statement. If the candidate will be working away from the home institution, signatures from both the home and the host institution are required. The sponsoring institution, through the submission of the application and in the institutional commitment section, certifies that all items outlined above will be provided and that the institution will abide by the applicable assurances and PHS policies. See: NOT-OD-06-054.

From the PA:

• The sponsoring institution must provide a statement of commitment to the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of the K99/R00 award.

• Provide assurances that the candidate will be able to devote a minimum of 9 person-months (75% of full-time professional effort) to the development of their research program. The remaining effort should be devoted to activities related to the development of the candidate’s career as an independent scientist.

• Provide assurance that the research facilities, resources, and training opportunities, including faculty capable of productive collaboration with the candidate, will be available for the candidate’s planned career development and research programs.

• Provide appropriate time and support for any proposed mentor(s) and/or other staff consistent with the career development plan.

• If the candidate is not a U.S. Citizen or permanent resident, the sponsoring institution must include information about their visa status and an assurance that the candidate’s visa provide sufficient time to complete both phases of the K99/R00 award at a U.S. Institution.

Review Criteria:

• To what extent does the institution provide a high quality environment for the candidate’s development?

• To what extent are the research facilities and educational opportunities, including collaborating faculty, adequate and appropriate for the candidate’s research and career development goals during the K99 phase of the award? What evidence is provided that the K99 sponsoring institution is strongly committed to fostering the candidate’s development and transition to the independent (R00) phase?

Is there adequate assurance that the required minimum of 9 person-months (75% of the candidate’s full-time professional effort) will be devoted directly to the research training, career development, and research activities described in the proposed career development and research plans?

Sections 10-11 The Research Plan (Section 10 is limited to one page; Section 11 PLUS sections 2-4 are limited to 12 pages total. You should figure on 6-8 pages for research, 4-6 pages for candidate information).

A Research Plan is required for all types of individual K awards. The Research Plan is the major component of the research career development plan. It is important to relate the research to the candidate's scientific career goals. Describe how the research, coupled with other developmental activities, will provide the experience, knowledge, and skills necessary to launch and conduct an independent research career, or enhance an established research career.

Your specific aims should reflect your training plan. Add an aim that requires techniques you will gain from your mentor or sponsors. In your “Potential problems, pitfalls, alternative approaches” paragraphs explain how any problems will lead you to additional career development. Remember: This grant is designed to fund your training. If you were writing a grant to fund your science, you’d be submitting an R21.

For most types of research, the plan should include: a specific hypothesis; a list of the specific aims and objectives that will be used to examine the hypothesis; a description of the methods/approaches/techniques to be used in each aim; a discussion of possible problems and how they will be avoided; and, when appropriate, alternative approaches that might be tried if the initial approaches do not work.

The plan should be appropriate to develop skills needed by a researcher. Projects that lack a clearly stated aim or hypothesis, such as studies involving routine data gathering to see where leads might develop and other types of descriptive projects, usually do not receive favorable recommendations from peer reviewers. This also applies to projects that are overly ambitious and describe more work than can be done in the requested time, as well as more routine projects that might be done, in large part, by a skilled technician.

Although candidates for mentored K awards are expected to write the Research Plan, the sponsor should review a draft of the plan and discuss it in detail with the candidate. Review by other knowledgeable colleagues is also helpful. The more people who read this several weeks before it’s submitted, the more likely it will get funded.

The Program Announcement describes the research strategy:

• The candidate should describe his/her research that is relevant to the proposed R00 research plan. Ideally, this would include a brief description of research performed prior to the mentored phase, a description of the research planned during the mentored phase and a detailed description of the research planned for the independent phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved). It is anticipated that candidates will be best able to describe their current and past research.

• The research description should demonstrate not only the quality of the candidate’s research thus far but also the novelty, significance, creativity and approach of the R00 phase research, as well as the ability of the candidate to carry out the research. Consequently, the research plan should provide a detailed rationale, experimental approach and plan for the independent phase research.

• The application must also describe the relationship between the mentor’s research and the candidate’s proposed research plan. The application should describe how the candidate will gain independence from his/her mentors and achieve separation of his/her scientific research program from that of the mentor(s).

• If more than one K99 phase mentor is proposed, the respective areas of expertise and responsibility should be described.

• Data and Safety Monitoring (when applicable): Individual NIH institutes may have specific requirements for data and safety monitoring of clinical trials. Candidates proposing to conduct clinical trials should consult with relevant IC staff. Plans for data and safety monitoring must be included in research plans involving Phase I or Phase II clinical trials: Generally, this requirement may be satisfied in the submitted application by providing documentation that the sponsoring institution has an approved plan in place and providing a brief description of the key elements of the plan.

Review Criteria:

• Is the proposed K99 phase research significant?

• Are the scientific and technical merits of the K99 research question, experimental design and methodology appropriate for the candidate’s level of training, an appropriate vehicle for developing the research skills described in the career development plan, and appropriate for developing a highly successful R00 research program?

• Is the proposed R00 phase research scientifically sound and a logical extension of the K99 phase research? Is there evidence of long-term viability of the proposed R00 phase research plan?

• Does the R00 phase project address an innovative hypothesis or challenge existing paradigms? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies?

• To what extent is the proposed R00 phase research likely to contribute significantly to our understanding of biomedical problems?

• To what extent is the proposed R00 phase research likely to foster the career of the candidate as an independent investigator in biomedical research?

10. Specific Aims One page

State precisely the goals of the proposed research and summarize the expected outcome(s) including the impact that the results of the proposed research will exert on the research field(s) involved.

List succinctly the specific objectives of the research proposed, e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.

I could write a whole document on how to create a strong specific aims page. I like to start with a powerful sentence that explains why we should care: Pancreatic cancer is the number four cancer killer, with five year survival rates of less than 95%. How many people get this disease? How much does it cost? How big is the impact? Read other people’s grants and the first paragraphs of good journal articles for illustrations. You need to establish that there is a problem, a data gap, a need for knowledge. Then your specific aims will fill this need. Strong sentences start with key words.

I think of this as five paragraphs—1) Set the stage for why we care. 2) Current state—then the data gap. 3) Description of how this gap could be filled. 4) Specific aims to state precisely how the gap will be addressed. 5) Summary paragraph wrapping it all up. Read lots of examples from other people to get a feel for this page.

I think that WHY specific aims tend to be more powerful than WHAT aims. Ex: SA1 as a “what”: Measure biomarkers of heart disease. Change it to a “why”: Measure biomarkers of heart disease to determine which biomarkers predict disease development in women at the earliest time points in a multivariable model.

I like to use the final paragraph as a wrap-up (tell them what you told them), with public health relevance if it fits. How will accomplishing your specific aims advance the field? Spell it out. My number one rule is to never let the reviewer draw his or her own conclusion—never make them think. Tell them what you just told them, then tell them why this is important, relevant research.

11. Research strategy (Significance, Innovation, and Approach)

Organize the Research Strategy in the specified order and using the instructions provided below. Start each section with the appropriate section heading – Significance, Innovation, Approach. Cite published experimental details in the Research Strategy section and provide the full reference in the Bibliography and References Cited section.

(a) Significance—why would anybody want to fund this research? Why do you want to do it?

• Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. (I like to describe diseases in terms of numbers—how many or what percentage of people are sick? How much money does treatment cost? How many school or work days are lost?).

• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. (You’re not going to solve the world’s problems, but what will be advanced?)

For training grants, I also like to include how important it is to the scientific community to train you in this area. Is autism a growing concern, so more scientists in this field will increase the likelihood that preventative measures or treatments will be found? Remember to refer back to your training and mentor plans as appropriate.

(b) Innovation

• Explain how the application challenges current research or clinical practice paradigms.

• Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.

If you are learning new (to you) techniques, this should be included in Section 4 and either Section 6 or 7—the mentor who will work with you to develop the new skill set should include this information in his or her section.

(c) Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 21 (Resource Sharing Plan), include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate.

• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. (Label this section as Potential Problems and Alternative Strategies).

• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in Item/Section 18.

There are numerous ways to put together a proposal. Some people like to do the Sign/Inn/App by specific aim, others like to describe the background and how this research will move the field forward in the significance section, then address specific aims in the approach as a research/methods plan.

12. Inclusion Enrollment Report (Renewal Applications only—you shouldn’t need this)

13. Progress Report Publication List—(Renewal Applications only; you don’t need this, either).

14. Protection of Human Subjects—if you’re using human subjects, this is an important section. The CEG IHSFC can assist with it.

15. Inclusion of Women and Minorities

16. Targeted/Planned Enrollment Table

17. Inclusion of Children

18. Vertebrate Animals—If you are using animals, this is an important document.

19. Select Agent Research

Select agents are hazardous biological agents and toxins that have been identified by DHHS or USDA as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. CDC maintains a list of these agents. See . If the activities proposed in your application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.4(f)(5), the select agent requirements do not apply. Use this section to identify the strain(s) of the select agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions at .

20. Consortium / Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. The signature of the Authorized Organization Representative on the SF424 (R&R) cover component (Item 17) signifies that the applicant and all proposed consortium participants understand and agree to the following statement: The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency’s consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.

21. Resource Sharing Plan(s) NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If you are developing something new (a transgenic mouse, GWAS data) tell us how you will share it.

22. Appendix

You are limited to ten items, and these are pretty restrictive. See

for details.

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